USPTO Patents Application 10677403

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria, Virginia 22313-1450
www.uspto.gov

| APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

10/677,403

10/01/2003

Sandeep Gulati

VIALO-27

8885

26686 7590 04/14/2004

CARL A. KUKKONEN, III

C/O WUESTHOFF & WUESTHOFF

SCHWEIGERSTRASSE 2

MUNICH, 81541

GERMANY

EXAMINER

KIM, YOUNG J

ART UNIT

PAPER NUMBER

1637

DATE MAILED: 04/14/2004

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

Office Action Summary

Application No.

10/677,403

Examiner

Young J. Kim

Applicant(s)

GULATI, SAN DEEP

Art Unit

1637

The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 MONTH(S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 1 33).
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1.704(b).

Status

1 )□ Responsive to communication(s) filed on .

2a)D This action is FINAL. 2b)K This action is non-final.

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quay/e, 1935 CD. 11, 453 O.G. 213.

Disposition of Claims

4) [>3 Claim(s) 1-12 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) D Claim(s) is/are allowed.

6) P Claim(s) is/are rejected.

7) D Claim(s) is/are objected to.

8) I3 Claim(s) 1-12 are subject to restriction and/or election requirement.

Application Papers

9) D The specification is objected to by the Examiner.

10) D The drawing(s) filed on is/are: a)D accepted or b)Q objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a).
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).

11) D The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 119

12) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f).
a)D All b)D Some * c)Q None of:

1 «D Certified copies of the priority documents have been received.

2.D Certified copies of the priority documents have been received in Application No. .

3.D Copies of the certified copies of the priority documents have been received in this National Stage
application from the International Bureau (PCT Rule 17.2(a)).
See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) □ Notice of References Cited (PTO-892)

2) O Notice of Draftsperson's Patent Drawing Review (PTO-948)

3) □ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08)

Paper No(s)/Mail Date .

4) □ Interview Summary (PTO-413)

Paper No(s)/Mail Date. .

5) □ Notice of Informal Patent Application (PTO-152)

6) □ Other: .

U.S. Patent and Trademark Office
PTOL-326 (Rev. 1-04)

Office Action Summary

Part of Paper No./Mail Date 03232004

Application/Control Number: 1 0/677,403 Page 2

Art Unit: 1637

DETAILED ACTION

Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:

I. Claims 1-5, drawn to a method of detecting the presence and the quantity of
specific analyte within a biological sample, a system conducting the method, and
a computer program product which executes the method, classified in class 706,
subclass 45.

II. Claims 6-12, drawn to a method of determining the effectiveness of a therapy by
analyzing a microarray output pattern, classified in class 435, subclass 6.

The inventions are distinct, each from the other because of the following reasons:

Inventions I and II are unrelated. Inventions are unrelated if it can be shown that they are
not disclosed as capable of use together and they have different modes of operation, different
functions, or different effects (MPEP § 806.04, MPEP § 808.01). In the instant case the different
inventions have different modes of operation, involving different steps. For example, the method
of Invention II is drawn to a method of determining the effectiveness of a therapy produced from
a microarray data generated from two or more biological samples, wherein the results are
analyzed and compared against a diffusion curve, which elucidates whether or not the therapy
was effective, while the method of Invention I is drawn to a simple detection of quantity of an
analyte in a biological sample by applying various parameters which compensates for the
background "noise" level in the digitized output. Such method could be applied to detect the
presence/absence or quantify the level of an analyte in a biological sample, which does not

Application/Control Number: 1 0/677,403 Page 3

Art Unit: 1637

require the correlation of whether a therapy is effective or not. Therefore, the methods are
different and the searches are not coextensive, resulting in a search burden.

Because these inventions are distinct for the reasons given above and have acquired a
separate status in the art because of their recognized divergent subject matter, restriction for
examination purposes as indicated is proper.

Applicants are advised that it appears that the Invention of II, if amended to recite all
elements of the product claims (or depend therefrom) encompassed in Invention I, would be
eligible for rejoinder under In re Ochiai. The practice of rejoinder under In re Ochiai is as
follows:

If an examiner required a restriction between product and process claims and Applicants
elect claims directed to the product, and a product claim is subsequently found allowable,
withdrawn process claims that depend from or otherwise include all the limitations of the
allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04.
Process claims that depend from or otherwise include all the limitations of the patentable
product will be entered as a matter of right if the amendment is presented prior to final rejection
or allowance, whichever is earlier. Amendments submitted after final rejection are governed by
37 CFR 1.1 16; amendments submitted after allowance are governed by 37 CFR 1.312.

In the event of rejoinder, the requirement for restriction between the product claims and
the rejoined process claims will be withdrawn, and the rejoined process claims will be fully
examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined
claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102,
103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction

Application/Control Number: 10/677,403 Page 4

Art Unit: 1637

requirement between product claims and process claims may be maintained. Withdrawn process
claims that are not commensurate in scope with an allowed product claim will not be rejoined .
See "Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re
Brouwer and 35 U.S.C. § 103(b)," 1 184 O.G. 86 (March 26, 1996). Additionally, in order to
retain the right to rejoinder in accordance with the above policy. Applicant is advised that the
process claims should be amended during prosecution either to maintain dependency on the
product claims or to otherwise include the limitations of the product claims. Failure to do so
may result in a loss of right to rejoinder.

Further, note that the prohibition against double patenting rejection of 35 U.S.C. 121 does
not apply where the restriction requirement is withdrawn by the examiner before the patent
issues. See MPEP § 804.01.

Finally, Applicants are advised that in the event of rejoinder, if the application containing
the rejoined claims is not in condition for allowance, the subsequent Office Action may be made
FINAL, or, if the application was already under FINAL rejection, the next Office Action may be
made an advisory action.

A telephone call was not made to request an oral election to the above restriction
requirement due to the complex nature of the requirement (MPEP § 812.01).

Applicant is advised that the reply to this requirement to be complete must include an
election of the invention to be examined even though the requirement be traversed (37 CRF
1.143).

Inquiries

Any inquiry concerning this communication or earlier communications from the
Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The

Application/Control Number: 10/677,403
Art Unit: 1637

Page 5

Examiner can normally be reached from 8:30 a.m. to 6:00 p.m. Monday through Thursday. If
attempts to reach the Examiner by telephone are unsuccessful, the Primary Examiner in charge
of the prosecution, Dr. Kenneth Horlick, can be reached at (571) 272-0784. If the attempts to
reach the above Examiners are unsuccessful, the Examiner's supervisor, Gary Benzion, can be
reached at (571) 272-0782. Papers related to this application may be submitted to Art Unit 1637
by facsimile transmission. The faxing of such papers must conform with the notice published in
the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993)
(see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should
be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE
SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official
documents must be sent to the Official Tech Center Fax number: (703) 872-9306. For Unofficial
documents, faxes can be sent directly to the Examiner at (517) 273-0785. Any inquiry of a
general nature or relating to the status of this application should be directed to the Group
receptionist whose telephone number is (571) 272-0507.

Young J. Kim
Patent Examiner
Art Unit 1637
3/23/04